FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Hematology ×
3,294 results
1633–1656 of 3,294
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Jan 23, 1992
ACTIVATED PARTIAL THROMBOPLASTIN TIME
K915463 · GGW
Sigma Diagnostics, Inc.
Hematology · 50d
Cleared Jan 17, 1992
DIFFERENTIAL COUNTING BOARD
K915071 · GKZ
Biovation, Inc.
Hematology · 70d
Cleared Jan 15, 1992
DADE(R) ALPHA 2 ANTIPLASMIN(2 2-AP) CHROMO ASSAY
K914818 · GGP
Baxter Diagnostics, Inc.
Hematology · 82d
Cleared Jan 13, 1992
CASCADE 480(TM) AUTO COAG ANALYZER, MODIFICATION
K914946 · GKP
Helena Laboratories
Hematology · 76d
Cleared Jan 08, 1992
MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGE
K915441 · GKF
Fisher Scientific Co., LLC
Hematology · 35d
Cleared Jan 06, 1992
PROTEIN S EID KIT AND PROTEIN S EID BULK PLATES
K915163 · GGP
Biopool AB
Hematology · 53d
Cleared Jan 03, 1992
ANTITHROMBIN III IMMUNOLOGICAL NL TEST KIT
K913667 · JBQ
The Binding Site, Ltd.
Hematology · 137d
Cleared Jan 03, 1992
COAMATE(R) ANTITHROMBIN CHROMOGENIC ASSAY
K915083 · JBQ
Kabi Pharmacia, Inc.
Hematology · 52d
Cleared Dec 30, 1991
SYSMEX NE-1500, MODIFICATION
K914744 · GKZ
Toa Medical Electronics USA, Inc.
Hematology · 69d
Cleared Dec 17, 1991
COLUMNMATE(TM) BETA-THAL CAT. NO. 4515
K913384 · JPD
Helena Laboratories
Hematology · 141d
Cleared Dec 09, 1991
SPECTROLYSE PROTEIN C KIT
K914307 · GGP
Biopool AB
Hematology · 75d
Cleared Dec 04, 1991
ACS ULTRA-1 THROMBOPLASTIN
K913249 · GJS
Analytical Control Systems, Inc.
Hematology · 135d
Cleared Dec 04, 1991
FACSTRAK FLOW CYTOMETER
K914014 · GKZ
Bd Becton Dickinson Vacutainer...
Hematology · 86d
Cleared Dec 02, 1991
FRUCTOSAMINE ABG21 TEST SYSTEM
K913614 · LCP
Boehringer Mannheim Corp.
Hematology · 111d
Cleared Nov 29, 1991
EPO-RIA
K910481 · GGT
Ramco Laboratories, Inc.
Hematology · 296d
Cleared Nov 27, 1991
ACS ULTRA-2 THROMBOPLASTIN
K913250 · GJS
Analytical Control Systems, Inc.
Hematology · 128d
Cleared Nov 27, 1991
CBC-8K(TM) HEMATOLOGY CONTROL/MULTIPLE
K913879 · JPK
R&D Systems, Inc.
Hematology · 90d
Cleared Nov 22, 1991
CELL-DYN 3000A MULTI-PARAMETER AUTO HEMA ANALZYER
K913305 · GKZ
Unipath , Ltd.
Hematology · 120d
Cleared Nov 19, 1991
SICKLE HEMOGLOBIN (HBA/S) CONTROL SET
K913427 · JCM
Creative Laboratory Products, Inc.
Hematology · 110d
Cleared Oct 31, 1991
MONOCLONAL ANTIBODY ANTI-CD19
K901186 · GKZ
Sigma Chemical Co.
Hematology · 597d
Cleared Oct 31, 1991
MONOCLONAL ANTIBODY ANTI-CD2
K901187 · GKZ
Sigma Chemical Co.
Hematology · 597d
Cleared Oct 31, 1991
MONOCLONAL ANTIBODY ANTI-CD5
K901188 · GKZ
Sigma Chemical Co.
Hematology · 597d
Cleared Oct 31, 1991
MONOCLONAL ANTIBODY ANTI-CD3
K901189 · GKZ
Sigma Chemical Co.
Hematology · 597d
Cleared Oct 31, 1991
CYTO-STAT(R)/COULTER CLONE(R) T11-RD1/B4-FITC
K910473 · GKZ
Coulter Immunology
Hematology · 269d